95,114 total recalls in our database
ECG interpretation feature issues. False measurements reported when the algorithm cannot determine P wave or QRS axis. The Median Complex Report displays the representative beat 25% larger than actual signal input. When a patient date of birth is imported from an external source, the ECG interpretation algorithm uses the default age of 50, and interpretive statements may be incorrect.
Smith & Nephew, Inc. Endoscopy Division
Sterility of device is compromised due to breach in sterile barrier
Integra LifeSciences
Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
Instrumentation Laboratory
Potential for sample misidentification.
Baxter Healthcare
Inadequate iodine and packaging related defects.
Instrumentation Laboratory
Potential for sample misidentification.
Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose.
During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
Terumo Cardiovascular Systems
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Smith & Nephew, Inc. Endoscopy Division
Sterility of device is compromised due to breach in sterile barrier
During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
Laser Peripherals
Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility expiration date as '2016-16' as opposed to the intended date of '2016-06'.
MTI Precision Products
Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.
Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.
Smith & Nephew, Inc. Endoscopy Division
Sterility of device is compromised due to breach in sterile barrier
Lack of Sterility Assurance
Smith & Nephew, Inc. Endoscopy Division
Sterility of device is compromised due to breach in sterile barrier
There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.